Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Strubergasse 21, 5020, Salzburg, Austria.
Wien Klin Wochenschr. 2012 Sep;124(17-18):639-46. doi: 10.1007/s00508-012-0226-x. Epub 2012 Aug 8.
We evaluated the disease management programme (DMP) "Therapie Aktiv" for diabetes mellitus type 2 during the first year of implementation in a cluster-randomised controlled trial (RCT), which revealed an improvement of process quality, but only insignificant effects on HbA1c. To further analyse the effects of the DMP we followed up participants of the RCT for another year.
After completion of the RCT, the study was continued as an open observational trial. By patient's choice, three groups were formed. Group 1 (DMP/DMP): interventions of the RCT (DMP), who remained in the DMP; group 2 (Control/DMP): controls of the RCT (usual care), who participated in the DMP during the second year; group 3 (Control/Control): controls of the RCT (usual care), who remained as controls.
HbA1c.
BMI, lipids, blood pressure and measures of process quality.
Only 801 of 1,489 RCT participants completed the study (53.8 %). Group 1: n = 355; group 2: n = 335; group 3: n = 111. After 2 years, pre-post-analysis revealed a significant reduction of HbA1c (0.37 %, p < 0.001) in both DMP groups, and a reduction of only 0.03 % (p = 0.975) in the control group. However, the difference between the groups was not significant (p = 0.065). There was a significant improvement of process quality in the DMP groups compared with controls.
The DMP clearly enhances process quality. Furthermore, the DMP yields a reduction of HbA1c within groups after 2 years, but significance is lost in between-group analysis. We conclude that the DMP has only a minor effect on metabolic control.
我们在一项群组随机对照试验（RCT）中评估了 2 型糖尿病疾病管理计划（DMP）“Therapie Aktiv”在实施的第一年的效果，结果显示该计划改善了治疗过程的质量，但对糖化血红蛋白（HbA1c）仅有轻微的影响。为了进一步分析该 DMP 的效果，我们对 RCT 的参与者进行了为期一年的随访。
在 RCT 完成后，该研究继续作为一项开放性观察性试验进行。根据患者的选择，将参与者分为三组。组 1（DMP/DMP）：接受 RCT 中的干预措施（DMP），并继续参加 DMP；组 2（Control/DMP）：接受 RCT 中的对照组（常规护理），在第二年参加 DMP；组 3（Control/Control）：接受 RCT 中的对照组（常规护理），继续作为对照组。
HbA1c。
BMI、血脂、血压和治疗过程质量的测量指标。
在 1489 名 RCT 参与者中，仅有 801 名完成了研究（53.8%）。组 1：n=355；组 2：n=335；组 3：n=111。经过 2 年的随访，前后分析显示，两组 DMP 组的 HbA1c 均显著降低（0.37%，p<0.001），而对照组仅降低 0.03%（p=0.975）。然而，组间差异无统计学意义（p=0.065）。与对照组相比，DMP 组的治疗过程质量显著改善。
DMP 明显提高了治疗过程的质量。此外，在 2 年内，DMP 组的 HbA1c 有所降低，但组间分析则失去了统计学意义。我们得出结论，DMP 对代谢控制的影响较小。
